Medicinal low density polyethylene film, bag quality control

Medicinal low-density polyethylene film and bag are widely used in the pharmaceutical industry. This paper mainly introduces the corresponding detection method by using the medicinal film produced by the rotting method and the blown film method (and the bag made by heat sealing). With test equipment. According to the standard of YBB00072005 "medicinal low-density polyethylene film and bag" published by the State Food and Drug Administration, the medicinal low-density polyethylene film and bag testing items mainly include: barrier properties (water vapor transmission and oxygen permeation) ), tensile strength, heat sealing strength and other indicators. In order to facilitate the medicinal low-density polyethylene film, bag manufacturers and pharmaceutical companies to better understand the specific requirements of YBB00072005, Jinan Languang Electromechanical Technology Co., Ltd. combined with "Languang Laboratory" and testing instruments are as follows:

Detection of barrier properties of medicinal low-density polyethylene film and bag

Test purposes:

Barrier performance is an important performance index for the examination of medicinal low-density polyethylene film and bag. It plays a key role in the control of rancidity, anti-tarnishing, anti-hardening and oil-water separation.

experiment method:

The water vapor transmission rate is determined according to the method of YBB00092003* method-cup method (gravimetric test), the test temperature (38±0.6°C), the test relative humidity (90±2)%, and the water vapor transmission rate is not more than 15g/m2.24h. The oxygen permeation amount is specified in accordance with the YBB00082003 standard method (pressure difference method for measuring oxygen permeation). The test temperature is 38 ± 2 ° C (the oxygen permeation amount shall not exceed 4000 cm3 / m 2.24 h. 0.1 Mpa.

Test Instruments:

The water vapor transmission test uses the TSH-T series moisture permeability tester of labthink blue light, and the oxygen permeability test is carried out by using the VAC series differential pressure gas permeation tester.

Medicinal low-density polyethylene film, bag mechanical properties (tensile strength, elongation at break) test

Test purposes:

Low-density polyethylene solid pharmaceutical film and bag need to bear the weight of the content in use, and also need some external force, so the mechanical properties should be measured and the mechanical properties should be qualified by testing.

Test method: The tensile strength method refers to the tensile property measurement method (YBB00112003), and the index is determined according to the experimental verification results. Generally, the average tensile strength in the longitudinal and transverse directions is not less than 10 MPa. The method of elongation at break refers to the tensile property measurement method (YBB00112003). The index is determined according to the experimental verification results. The film with a thickness of less than 0.05 mm requires an average elongation of not less than 130%; a film larger than 0.05 mm requires vertical and horizontal The average elongation at break shall not be less than 200%.

Test Instruments:

Labthink Languang's XLW series of intelligent electronic tensile machines can be used for inspection. Samples are prepared according to the standard regulations, and then clamped on the upper and lower clamps of the intelligent electronic tensile testing machine to set the test speed (recommended speed of 500mm/min is recommended). ), start the test and test the test results.

Pharmaceutical low density polyethylene film, bag heat sealing strength test

Test purposes:

Detection of heat-sealing strength of heat-sealed parts after film is formed into bags

experiment method:

Tested according to the YBB00122003 standard. Cut 4 pieces of 100mm*100mm diaphragm, stack any two diaphragms, put them on the heat sealer for hot pressing sealing, heat sealing temperature 130-150°C, pressure 0.22Mpa, heat sealing time 1 second, heat sealing required The strength is not less than 7.0N/15mm.

Test Instruments:

The HST-H3 type heat seal tester of Labthink can be used to prepare the heat-sealed sample, and then the XLW series intelligent electronic tensile tester can be used for the heat-sealing strength test. will

The above information is specially arranged by Jinan Languang Electromechanical Technology Co., Ltd. , in order to help the quality control of medicinal composite ointment tube manufacturing and use enterprises. At the same time, our company also has a professional laboratory to carry out the testing of all the above projects, hoping to Industry colleagues exchanged more questions.

For more information, please call Zhang Jianbo (), headquarter of Jinan Languang Electromechanical Technology Co., Ltd.

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